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New treatment option for Advanced or Metastatic Solid Tumors
Official title A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
ClinicalTrials.gov ID: NCT05753722
What this study is testing
What is PRTH-101?
PRTH-101 is an investigational medicine, being studied as a potential treatment for advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be willing and able to read, understand, and sign an Informed Consent Form.
- Subject must be age ≥18 years.
- Subject has metastatic or advanced, unresectable malignancy and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as...
- Subject has a pathologically documented advanced/unresectable or metastatic cancer that is refractory to or intolerable to or the subject is...
- Subject must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.
You likely can't join if
- Subject has received prior treatment with systemic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates...
- Subject has ongoing toxicity from prior therapy \>Grade 1 according to the CTCAE, with the following exceptions. Such exceptions must be assessed by...
- Alopecia, and vitiligo
- Grade ≤2 neuropathy
- Well-controlled hypo/hyperthyroidism or other endocrinopathies that are well controlled with hormone replacement
- Subject has undergone a major surgery (excluding minor procedures e.g., placement of vascular access) \<2 months prior to administration of PRTH-101.
See the full eligibility criteria
Who can join
- Subject must be willing and able to read, understand, and sign an Informed Consent Form.
- Subject must be age ≥18 years.
- Subject has metastatic or advanced, unresectable malignancy and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed at Screening, excluding hepatocellular carcinoma, sarcomas...
- Subject has a pathologically documented advanced/unresectable or metastatic cancer that is refractory to or intolerable to or the subject is unwilling or ineligible to receive standard treatment known to confer benefit...
- Subject must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.
- Subject must have a predicted life expectancy of ≥3 months.
- Subject must have the following laboratory values (obtained ≤14 days prior to enrollment):
- Calculated creatinine clearance must be ≥30 mL/min by Cockcroft-Gault formula calculation
- Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (in which case, total bilirubin must be ≤3 × ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN, or ≤3 x ULN in the presence of liver metastases
- Hemoglobin ≥9.0 g/dL
- Platelets ≥100 × 109 cells/L 9
- Absolute neutrophil count ≥1.5 ×10 cells/L (without the use of hematopoietic growth factors)
- Corrected QT interval (QTc) ≤470 milliseconds (as calculated by the Fridericia correction formula)
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 3 days prior to first administration of PRTH-101.
- WOCBP and males with female partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last dose of PRTH-101.
- Subject must be willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
- Subject must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines or have archived tissue available (Section 12.3) at enrollment. a. people...
- The subject is not enrolled in any other clinical trial and is not receiving other therapy directed at their malignancy.
- The subject is willing to undergo pre-and post-treatment skin biopsies.
What rules you out
- Subject has received prior treatment with systemic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines, and monoclonal antibodies (e.g., checkpoint inhibitors)...
- Subject has ongoing toxicity from prior therapy \>Grade 1 according to the CTCAE, with the following exceptions. Such exceptions must be assessed by the Investigator (and approved by the Sponsor) as not placing the...
- Alopecia, and vitiligo
- Grade ≤2 neuropathy
- Well-controlled hypo/hyperthyroidism or other endocrinopathies that are well controlled with hormone replacement
- Subject has undergone a major surgery (excluding minor procedures e.g., placement of vascular access) \<2 months prior to administration of PRTH-101.
- Subject has received radiation therapy \<28 days prior to administration of PRTH-101. a. Exception: limited (e.g., pain palliation) radiation therapy is allowed prior to and during study treatment as long as there are...
- Subject has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time.
- Subject has a diagnosis of immunodeficiency, either primary or acquired.
- Subject has received treatment with systemic steroids or any other form of immunosuppressive therapy within 14 days prior to administration of PRTH-101. a. Exception: inhaled or topical (to include mouthwash) steroids...
- Subject has an active or prior history of autoimmune disease requiring immunosuppressive therapy. Exceptions can be made in discussion with the medical monitor.
- Subject has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins (e.g., soluble receptors or other Fc fusion proteins), or IV immunoglobulin preparations; prior...
- Subject has Central Nervous System (CNS) tumor involvement not definitively treated with surgery or radiation that is active (including evidence of cerebral edema by MRI, or progression from prior imaging study, or has...
- Subject has leptomeningeal carcinomatosis, regardless of treatment history.
- Subject has current second malignancy at other sites (exceptions: nonmelanomatous skin cancer, adequately treated in situ carcinoma [e.g., cervical], or indolent prostate cancer under observation). A history of other...
- Subject has active and clinically significant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or HIV (testing not required).
- Subject has received live vaccines within the past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date \>30 days prior to administration of PRTH-101).
- Women who are pregnant or breastfeeding.
- History of any of the following ≤6 months before first dose: a. Congestive heart failure New York Heart Association Grade III or IV b. Unstable angina c. Myocardial infarction d. Unstable symptomatic ischemic heart...
- Subject has any contraindications to the imaging assessments or other study procedures that people will be undergoing.
- Subject has any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical study data interpretation.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States; Portland, Oregon, United States; Pittsburgh, Pennsylvania, United States; Nashville, Tennessee, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.